MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED.CATHETER; PERIPHERAL CATHETERS

Catalog Number 510038CB2/CN

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2021

Event Type  Injury  

Event Description

The account alleges that during a uterine artery embolization [uae] procedure the catheter tip detached within the patient's artery.The physician acquired vascular access via seldinger technique to insert the 5f sheath using a pig tail catheter to enter the lower part of the abdominal aorta for fluoroscopic imaging.The bilateral uterine arteries were obviously thickened and tortuous.The 5f angiography catheter was inserted through the sheath, and an ultra-smooth guide wire was used to perform the angiography of the left internal iliac artery.It was found that the anterior segment of the angiography catheter had kinked and bent.During an attempt to gently withdraw the angiography catheter it completely detached within the patient.After inserting a vascular snare device, the broken angiography catheter was successfully captured.When trying to remove the angiography catheter, again the foreign body ruptured.Fluoroscopic inspection demonstrated that a 10mm foreign body remains within the terminal branch of the left deep femoral artery.Several attempts were made to retrieve the foreign body, but they were unsuccessful.General surgery was consulted for emergent surgical extraction of the remaining foreign body.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: IMPRESS®.BRAIDED.CATHETER
• Type of Device: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 13050105
• MDR Text Key: 284517073
• Report Number: 3010665433-2021-00126
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450035832
• UDI-Public: 884450035832
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2023
• Device Catalogue Number: 510038CB2/CN
• Device Lot Number: E1783959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE.
• Patient Outcome(s): Required Intervention; Other; Hospitalization